IP Library Granted Patent US 12,465,731
Granted Patent B2
US 12,465,731 · App. 17/544,204 · Granted Nov 11, 2025

Methods of manufacturing nested balloons utilizing pressurized constrained annealing

Inventors: Eric Mabry (Trabuco Canyon, CA); Matthew F. Tonge (Costa Mesa, CA); Don Ngo-Chu (Milpitas, CA); Kevin Justin Herrera (Sherman Oaks, CA)
Assignee: Confluent Medical Technologies, Inc.
A61M25/1029A61M25/1011B29C49/00B29C65/022A61M2025/1013A61M2025/1031A61M2025/1075B29L2031/7543
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Quick Facts
Patent No.
US 12,465,731
App. No.
17/544,204
Granted
Nov 11, 2025
Kind
B2
Abstract

A nested balloon is provided where each balloon is formed from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, nested balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such nested balloons using existing balloon forming equipment are also provided. The nested balloons can have layers with low-friction surfaces. The nested balloons are preferably manufactured using a variety of methods, including pressurized constrained annealing.

Claims (25)

1 . A nested balloon formed by the method comprising:

providing a first balloon layer;

providing a second balloon layer;

inserting the first balloon layer into the second balloon layer to form a nested balloon;

constrained pressurized annealing the first balloon layer and the second balloon layer at a temperature of between about 200° F. and about 300° F. for a time period of between about 10 minutes and about 90 minutes;

wherein constrained pressurized annealing comprises pressurizing the nested balloon at a pressure of between about 2 atm and about 30 atm,

wherein a lot of nested balloons after constrained pressurized annealing comprises a higher minimum burst strength as a result of a lower percentage standard deviation compared with a lot of nested balloons not employing constrained pressurized annealing, and

wherein the first balloon layer is configured to slide relative to the second ballon layer.

2 . The nested balloon of claim 1 , wherein the nested balloon comprises a lower compliance relative to the nested balloon not employing constrained pressurized annealing.

3 . The nested balloon of claim 1 , wherein the first balloon layer comprises nylon.

4 . The nested balloon of claim 1 , wherein the second balloon layer comprises nylon.

5 . The nested balloon of claim 1 , wherein the first balloon layer is a co-extruded balloon layer.

6 . The nested balloon of claim 1 , wherein the second balloon layer is a co-extruded balloon layer.

7 . The nested balloon of claim 1 , further comprising a third balloon layer, wherein the first balloon layer, the second balloon layer, and the third balloon layer are nested together.

8 . The nested balloon of claim 1 , wherein the first balloon layer and the second balloon layer are blown and nested within the same day.

9 . The nested balloon of claim 1 , wherein the constrained pressurized annealing temperature is between about 215° F. and about 255° F.

10 . The nested balloon of claim 1 , wherein the pressure is between about 10 atm and about 25 atm.

11 . The nested balloon of claim 1 , wherein the method further comprises stretching the balloon with a stretch force of between about 1 pound and about 5 pounds.

12 . The nested balloon of claim 1 , wherein the time period is between about 15 minutes and about 45 minutes.

13 . The nested balloon of claim 1 , wherein the time period is at least 30 minutes.

14 . The nested balloon of claim 1 , wherein the constrained pressurized annealing occurs in an enclosed balloon heating chamber configured with a controller.

15 . The nested balloon of claim 1 , wherein the nested balloon is welded to an inner and/or outer shaft of a catheter.

16 . The nested balloon of claim 1 , wherein the method further comprises sterilizing the nested balloon after constrained pressurized annealing at a temperature of between about 40° C. and about 60° C. for a time period of between about 1 hour and about 3 hours.

17 . The nested balloon of claim 1 , wherein the method further comprises blow molding the first balloon layer and the second balloon layer prior to constrained pressurized annealing.

18 . The nested balloon of claim 17 , wherein the blow molding occurs no more than about 48 hours prior to constrained pressurized annealing.

Assignments (3)
SECURITY INTEREST Recorded Jul 27, 2026
From: CONFLUENT MEDICAL TECHNOLOGIES, INC.
To: JPMORGAN CHASE BANK, N.A, AS COLLATERAL AGENT
Reel/Frame 075406/0016 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 21, 2025
From: INTERFACE ASSOCIATES, INC.
To: CONFLUENT MEDICAL TECHNOLOGIES, INC.
Reel/Frame 072087/0343 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2022
From: MABRY, ERIC; TONGE, MATTHEW F.; NGO-CHU, DON; HERRERA, KEVIN JUSTIN
To: INTERFACE ASSOCIATES, INC.
Reel/Frame 059019/0193 →
Continuity (4)
Continuation 17018884 · Sep 11, 2020
Continuation 14924278 · Oct 27, 2015
Provisional Application 62069303 · Oct 27, 2014
Related Publication 20220161008A1 · May 26, 2022
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